Biophysical Profile in Preterm Pregnancies

Fetal Development Clinical Trial

— BPP  

Official title:

Pattern of Human Fetal Biophysical Profile Scoring in Relationship to Gestational Age.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02561364
• Other study ID #: 15-03853-XP
• Status: Completed
• Start date: October 2015
• Est. completion date: March 2017

Study information

• Verified date: October 2016
• Source: University of Tennessee
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The purpose of this study is to evaluate the fetal biophysical profile (BPP) scoring in pregnant women from 20 weeks-0 days' to 36 weeks-6 days' gestation. A biophysical profile (BPP) is a score that is intended to assess fetal well-being. This test will be performed within the expected time of the routine ultrasound exam.

Description:

1. PURPOSE: To determine whether human fetal biophysical profile (BPP) scoring varies according to gestational age in preterm pregnancies.

2. RATIONALE: Fetal BPP and non-stress tests (NST) are useful tools in the assessment of fetal well-being in term fetuses. While for NST it has been established that the criteria for reassuring well-being are less strict in premature fetuses below 32 weeks' gestation, the pattern of BPP scoring according to preterm gestational age has not been fully investigated. The investigators consider that in premature fetuses, a reassuring BPP scoring does not need to be as strict as that used in term fetuses.

3. STUDY/PROJECT POPULATION:

The Investigators' aim to use BPP scoring during routine ultrasound visits that pregnant patients undergo as part of their prenatal care. A routine ultrasound visit is performed during 30 to 60 minutes. The use of BPP will not add additional time to that taken by the routine ultrasound visit.

The investigators will use BPP scoring in women from 20 to 36 weeks' gestation who attend routine ultrasound visits at the MedPlex Outpatient Clinic - Regional One Health. The sonographers are trained in the performance of BPP. The investigators will include women with singleton and multiple pregnancies who are able to provide informed consent.

The investigators will exclude women who do not consent for the study, those unable to provide informed consent, and those with lethal fetal anomalies.

4. RESEARCH DESIGN Descriptive study with prospective collection of data.

5. STUDY/PROJECT PROCEDURES:

The study will involve the performance of a biophysical profile (BPP) scoring during routine ultrasound exams. The BPP is not intended to last more than 30 minutes. A BPP score is composed by ultrasound assessment of:

• amniotic fluid volume (normal = 2 points, low = 0 points)

• fetal movements (3 or more movements = 2 points, less movements = 0 points); we will record the total number of movements during the testing period

• fetal breathing (sustained 30 second breathing = 2 points, <30 seconds = 0 points); we will record time of sustained breathing during the testing period

• fetal tone (extension and flexion = 2 points, lack of extension/flexion = 0 points) For those patients undergoing standard of care scheduled BPP, information will be abstracted from the scheduled test.

For those patients undergoing standard of care ultrasound but are not scheduled for BPP, additional BPP will be obtained within the time allotted for the already scheduled ultrasound.

The investigators will correlate the BPP scoring with the non-stress test (NST) or Doppler flow reports in those fetuses already undergoing NST or Doppler studies for other obstetric indications not related to the purpose of this study.

6. OUTCOME MEASURES:

Primary outcome: fetal or neonatal survival

Secondary outcomes:

• gestational age at delivery

• need for NST

• hospitalization

• need for antenatal steroids use

• fetal growth restriction

• spontaneous or indicated preterm delivery

• neonate apgars

• neonatal morbidity: respiratory, gastrointestinal, neurologic, metabolic

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• pregnant women between 20 wks 0 days and 36 wks and 6 days

• singleton or multiple pregnancies

• able to provide informed consent

• age 18 to 45 years old

Exclusion Criteria:

• lethal fatal anomalies

• those not providing informed consent

Related Conditions & MeSH terms

• Fetal Development

Locations

Country	Name	City	State
United States	Regional One Health Center for High Risk Pregnancies	Memphis	Tennessee
United States	Regional One Health Ob-Gyn Clinic	Memphis	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
University of Tennessee

Country where clinical trial is conducted

United States, 

References & Publications (9)

American College of Obstetricians and Gynecologists. Practice bulletin no. 116: Management of intrapartum fetal heart rate tracings. Obstet Gynecol. 2010 Nov;116(5):1232-40. doi: 10.1097/AOG.0b013e3182004fa9. — View Citation

Baskett TF. Gestational age and fetal biophysical assessment. Am J Obstet Gynecol. 1988 Feb;158(2):332-4. — View Citation

Druzin ML, Fox A, Kogut E, Carlson C. The relationship of the nonstress test to gestational age. Am J Obstet Gynecol. 1985 Oct 15;153(4):386-9. — View Citation

Druzin ML, Smith JF, Gabbe SG, Reed KL, Antepartum Fetal Evaluation. In: Gabbe SG, Niebyl JR Simpson JL, editors. Obstetrics: normal and problem pregnancies. 5th ed. Philadelphia (PA): Churchill Livingstone; 2007. p. 267-300.

Gagnon R, Campbell K, Hunse C, Patrick J. Patterns of human fetal heart rate accelerations from 26 weeks to term. Am J Obstet Gynecol. 1987 Sep;157(3):743-8. — View Citation

Harman, CR. Assessment of Fetal Health. In: Creasy RK, Resnik R, Iams JD, Lockwood CJ, Moor TM, editors. Maternal-fetal medicine: principle and practice. 6th ed. Philadelphia (PA):Saunders 2009. p. 361-95.

Macones GA, Hankins GD, Spong CY, Hauth J, Moore T. The 2008 National Institute of Child Health and Human Development workshop report on electronic fetal monitoring: update on definitions, interpretation, and research guidelines. Obstet Gynecol. 2008 Sep;112(3):661-6. doi: 10.1097/AOG.0b013e3181841395. — View Citation

Natale R, Nasello C, Turliuk R. The relationship between movements and accelerations in fetal heart rate at twenty-four to thirty-two weeks' gestation. Am J Obstet Gynecol. 1984 Mar 1;148(5):591-5. — View Citation

Sorokin Y, Dierker LJ, Pillay SK, Zador IE, Schreiner ML, Rosen MG. The association between fetal heart rate patterns and fetal movements in pregnancies between 20 and 30 weeks' gestation. Am J Obstet Gynecol. 1982 Jun 1;143(3):243-9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fetal or neonatal survival measured as live birth or fetal demise	will be monitored and recorded on all participants	20 weeks 0 days up to 36 weeks and 6 days
Secondary	gestational age at delivery as measured by ultrasound calculations	will be monitored and recorded on all participants	20 weeks 0 days up to 36 weeks and 6 days
Secondary	need for non-stress test as necessary for related health issue, determined by the health history and measured by occurrence with supporting health documentation	will be monitored and recorded on all participants	20 weeks 0 days up to 36 weeks and 6 days
Secondary	hospitalization measured as necessary for related health issue with documentation of procedures and length of stay	will be monitored and recorded on all participants	20 weeks 0 days up to 36 weeks and 6 days
Secondary	need for antenatal steroids use as indicated for high risk of preterm delivery measured as necessary for related health issue, and utilized.	will be monitored and recorded on all participants	20 weeks 0 days up to 36 weeks and 6 days
Secondary	fetal growth restriction (FGR) measured by American College of Obstetricians and Gynecologists (ACOG): FGR: Fetus-estimated weight below 10th percentile. small for gestational age (SGA): Newborns-weight below the 10th percentile for gestational age.	will be monitored and recorded on all participants	20 weeks 0 days up to 36 weeks and 6 days
Secondary	spontaneous or indicated preterm delivery documented as occurring or necessary for related health issue	will be monitored and recorded on all participants	20 weeks 0 days up to 36 weeks and 6 days
Secondary	neonate apgar scores measured at birth: At 1 minute and 5 minutes (scoring 0, 1,or 2 in 5 physiological functions: Activity (muscle tone), Pulse (heart rate), Grimace (reflex response), Appearance (color), and Respiration (breathing)].	will be monitored and recorded on all participants	20 weeks 0 days up to 36 weeks and 6 days
Secondary	Number of neonates born with morbid conditions: respiratory, gastrointestinal, neurologic, metabolic; documented as present.	will be monitored and recorded on all participants	20 weeks 0 days up to 36 weeks and 6 days